TracPatch Wearable Device for Knee Replacement Surgery Recovery

Overseen By Victor B Hernandez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnant, Prisoners, Complex arthroplasty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new wearable device called the Consensus TracPatch, designed to aid recovery from knee replacement surgery. The device tracks movement, temperature, and steps, providing real-time feedback to patients and doctors to enhance recovery and communication. Participants will either use the TracPatch or follow standard care for comparison. This trial suits individuals scheduled for knee replacement surgery who have a smartphone with Bluetooth. As an unphased trial, it offers a unique opportunity to contribute to innovative recovery solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TracPatch wearable device is safe for knee replacement surgery recovery?

Research shows that the Consensus TracPatch, a wearable device, aids in tracking recovery after knee replacement surgery. Studies have found that sensors in the device monitor movement, temperature, and steps, helping doctors assess knee healing.

Although specific data on the TracPatch's safety is unavailable, wearable devices like this are generally considered safe. They are non-invasive, meaning they do not enter the body. So far, no major issues have been reported with this type of technology.

This study is not in a specific phase, focusing on the device's effectiveness and usability rather than just safety. This suggests earlier tests likely demonstrated its safety. Always consult a healthcare provider before joining a clinical trial to understand all potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TracPatch wearable device because it offers a novel way to enhance recovery from knee replacement surgery. Unlike traditional methods that rely on in-person physical therapy and regular check-ups, TracPatch allows for continuous, real-time monitoring of a patient's progress through a wearable device. This technology provides personalized insights and feedback, enabling quicker adjustments to recovery plans, potentially speeding up the healing process. Additionally, it offers the convenience of remote monitoring, reducing the need for frequent hospital visits. This approach could revolutionize post-operative care by making it more efficient and tailored to individual needs.

What evidence suggests that the TracPatch wearable device is effective for knee replacement recovery?

Research has shown that wearable devices like the Consensus TracPatch can significantly aid recovery after knee surgery. In this trial, participants in the Wearable Technology Group will use the Consensus TracPatch, which studies have shown improves knee scores, indicating better recovery post-surgery. These devices provide real-time information on movement and recovery, allowing doctors to monitor and adjust treatment more effectively. They also enhance communication between patients and doctors, leading to improved outcomes. Overall, the TracPatch appears promising in helping patients move better after knee replacement surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Victor H Hernandez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are about to have knee replacement surgery due to osteoarthritis and can consent. They must be able to use a smartphone with Bluetooth. It's not for those who've had the same surgery on that knee, have severe knee deformities, or complex cases as judged by their surgeon.

Inclusion Criteria

Have signed the written informed consent form

Have consistent access to an iOS or Android device with Bluetooth capability

I am eligible for a total knee replacement surgery.

Exclusion Criteria

My joint is bent or twisted more than 10 degrees.

Wards of the state

I have had a total knee replacement on the same knee before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Consensus TracPatch wearable device postoperatively and are instructed on its use for six weeks

6 weeks

Regular monitoring via wearable device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Consensus TracPatch

Trial Overview The study tests the Consensus TracPatch, a wearable device tracking recovery after knee surgery using motion and temperature sensors. It aims to improve post-op mobility and patient-doctor communication by providing real-time data.

How Is the Trial Designed?

Group I: Wearable Technology Group Experimental Treatment 1 Intervention

Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Group II: Current Standard of Care Group Active Control 1 Intervention

Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Consensus Orthopedics

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

A new wearable device was developed to measure joint flexion and physical activity, showing strong correlation with traditional motion capture systems, making it a reliable tool for assessing post-operative recovery.

In a study with pigs after knee surgery, the device revealed that physical activity decreased immediately post-surgery but returned to pre-operative levels within two weeks, highlighting its potential for monitoring recovery in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Magnet-Based System to Assess Activity and Joint Flexion in Humans and Large Animals. Qu, F., Stoeckl, BD., Gebhard, PM., et al.[2019]

Patients using a front-wheeled walker after total knee replacement (TKR) surgery demonstrated faster walking velocity and longer step lengths immediately after surgery compared to those using a standard walker, indicating a potential short-term benefit in mobility.

However, by six weeks post-surgery, both walker groups showed similar improvements in walking speed and endurance, suggesting that while the wheeled walker may aid initial recovery, it does not lead to greater long-term ambulation benefits or reduced therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. Pasquini, SM., Peterson, ML., Rattansi, SM., et al.[2010]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0883540325012136

Efficacy of Lower Limb Wearables to Assess Recovery ... Postoperative outcomes showed significant improvements in the Oxford Hip Score (P < 0.001), Oxford Knee Score (P = 0.020), and University of ...

2. tracpatch.com tracpatch.com/

TracPatch TracPatch is paving the way for better patient-provider connection. Through remote patient monitoring, providers now have better insight into patient recovery.

3. orthostreams.com orthostreams.com/tracpatch/

Everything you need to know about the first wearable ... TracPatch is a cutting-edge medical wearable designed to make recovering at home easily accessible, connected, and more predictable.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297050/

The role of commercially available smartphone apps and ... Commercially available smartphone apps and wearable devices were shown to capably monitor physical activity and improve patient engagement following TKA, making ...

5. clinicaltrial.be clinicaltrial.be/en/details/69168?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

TracPatch in Total Knee Arthroplasty The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38823517/

Normative Values for Daily Functional Recovery Patterns ... To our knowledge, this study presents the first normative data for tracking daily functional recovery in TKA patients using wearable sensors ...

7. tracpatch.com tracpatch.com/remote-monitoring-using-wearable-technology-after-knee-arthroplasty

Remote Monitoring using Wearable Technology after Knee ... This study demonstrates that remote monitoring using knee specific surface sensors can capture the expected recovery kinetics following knee ...

8. news.med.miami.edu news.med.miami.edu/device-for-remote-patient-monitoring-after-knee-replacement-shows-promise/

Device for Remote Patient Monitoring After Knee ... - InventUM A digital device worn by patients continuously for several weeks after they have had a total knee replacement aims to improve clinical outcomes while reducing ...

9. ctv.veeva.com ctv.veeva.com/study/tracpatch-in-total-knee-arthroplasty

TracPatch in Total Knee Arthroplasty - ClinicalTrials.Veeva The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery.